MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121146

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Pain (1994); No Code Available (3191)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed in (b)(6) 2007 from resurfacing to thr.Implanted (b)(6) 2006.Subsequent revision scheduled (b)(6) 2018, see subsequent mdr for related case.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to pain, changes of position of the implant and changes in x-ray that suggest avascular necrosis.During the revision the bhr head was removed.The bhr cup remained implanted.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.The available medical documents were reviewed.It was reported that approximately 3 months following implantation, the patient was revised due to a ¿change of position of the implant¿ secondary to suspected avascular necrosis of the femoral head.The explanted components were then sent to the laboratory to rule out avascular necrosis; however, no laboratory results were provided.It was noted intraoperatively that there was no clear evidence of avascular necrosis within the cut section of the femoral neck; however, ¿there was a possible portion of scar tissue that may have represented an old neck fracture.¿ no supporting lab/pathology results, imaging, and/or the analysis of the explanted components were provided that could explain the reported avascular necrosis, the possible femoral neck fracture, and mal-positioned explant which resulted in the initial revision without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the bhr head was removed.The bhr cup remained implanted.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.The available medical documents were reviewed.X-rays showed a change in the implant position which was suggestive of avascular necrosis.There are areas of necrosis consistent with aseptic necrosis associated with degenerative changes in the surface.The history of degenerative joint disease could have also been a contributing factor to the clinical status of the patient.With the information provided, it is unknown if these contraindications contributed to the clinical status of avascular necrosis.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported fracture cannot be confirmed, and it cannot be concluded that the reported event was associated with a mal-performance of the implant.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: RESURFACING FEMORAL HEAD 46MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, CV313 HL; UK CV313HL
• MDR Report Key: 7673787
• MDR Text Key: 113539863
• Report Number: 3005975929-2018-00252
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2011
• Device Catalogue Number: 74121146
• Device Lot Number: 61916
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETLR CUP 54MM 74120154 LOT 59501
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 42 YR